COVIDIEN Recalls 8Fr Argyle Suction Catheter Kits with Chimney Valve
COVIDIEN LLC is recalling 32,071 units of 8Fr Argyle Suction Catheter Kits with Chimney Valve, Model 36826, because they were distributed while subject to importation refusal.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text does not report specific injuries, illnesses, or deaths, and the hazard is procedural (distribution during importation refusal) rather than a confirmed high-risk pathogen or structural defect causing harm.
Plain-English summary
COVIDIEN LLC is recalling 32,071 units of 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826. The recall is being conducted because the product was released into commercial distribution while subject to importation refusal.
The affected products, identified by Lot Number 1816211264, were distributed to healthcare facilities in the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
Healthcare providers should stop using the affected products and contact COVIDIEN LLC for further instructions. The source text does not specify specific health hazards or reported injuries associated with this recall.
The recalled product
- Product
- 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
- Manufacturer
- COVIDIEN LLC
- Hazard
- Affected units
- 32,071
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number 1816211264
Distribution
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